NCT00003194

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 1997

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2002

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

5.5 years

First QC Date

April 6, 2000

Last Update Submit

April 3, 2019

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
cyclophosphamideDRUG
etoposideDRUG
thiotepaDRUG
topotecan hydrochlorideDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age1 Year - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically proven recurrent or refractory pediatric solid tumor * Bone marrow metastases allowed PATIENT CHARACTERISTICS: Age: * 1 to 30 Performance status: * 0-2 Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 100,000/mm3 (transfusion independent) * Hemoglobin at least 10 g/dL (RBC transfusion allowed) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 2.5 times normal Renal: * Adequate renal function as defined by one of the following: * GFR by creatinine clearance * Radioisotope GFR * Iothalamate at least 70 mL/min Cardiovascular: * Adequate cardiac function as defined by one of the following: * Ejection fraction at least 55% by MUGA * Fractional shortening at least 28% by echocardiogram Neurologic: * Adequate CNS function as defined by: * Seizure disorder, if present, controlled by anticonvulsants * CNS toxicity no greater than grade 2 Other: * No uncontrolled infections * Not pregnant or nursing * No allergy to platinum compounds * No history of allergy to etoposide (unless mobilization phase not required) PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy * At least 1 week since prior cytokines * At least 3 months since prior bone marrow or peripheral blood stem cell transplantation * No concurrent immunomodulator * No concurrent cytokines Chemotherapy: * At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered * No prior thiotepa * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Recovered from prior radiotherapy * At least 6 months since prior total body irradiation conditioning * No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Interventions

FilgrastimCarboplatinCyclophosphamideEtoposideThiotepaTopotecanPeripheral Blood Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Douglas Hawkins, MD

    Seattle Children's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 6, 2000

First Posted

January 27, 2003

Study Start

July 1, 1997

Primary Completion

December 19, 2002

Study Completion

December 19, 2002

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

US(2)